General Pharmacy Practice Frequently Asked Questions

General Pharmacy Practice Frequently Asked Questions I. Can pharmacy technicians engage in remote medication order processing or perform order entry from a remote location? A. Yes , but pharmacists should ensure ancillary personnel or interns are supervised in a manner that meets the Pharmacy Commission's definition of “immediate supervision.” Immediate supervision is defined in WAC 246-945-001(44). This includes the ability of pharmacists to employ technological means for the supervision of ancillary personnel or interns remotely. Pharmacists are encouraged to review WAC 246- 945-001(44) in its entirety when remotely supervising ancillary personnel or interns. II. Does the Uniform Controlled Substance Act (RCW 69.50) restrict the quantity of controlled substances that may be prescribed? A. The Uniform Controlled Substances Act (UCSA), RCW 69.50, does not limit the quantity of controlled substances (including those drugs listed in Schedule II) that may be prescribed . However, prescribers, and pharmacists, should be aware of specific prescribing laws that may apply to their profession . For example, a number of prescribing boards and commissions have specific laws and rules applicable to prescriptions for opioids. The USCA does prohibit refills for a drug listed in Schedule II (see RCW 69.50.308(d)). The USCA also prohibits filling of a prescription for a drug listed in Schedule II more than six months after the date the prescription was issued (see RCW 69.50.308(d)). The USCA prohibits more than five refills of a prescription for a drug listed in Schedule III, IV, or V (see RCW 69.50.308(g)). In addition, the USCA prohibits filling or refilling of a prescription for a drug listed in Schedule III, IV, or V, more than six months after the date issued by the prescriber (see RCW 69.50.308(g)). B. Note: The Pharmacy Commission cannot guarantee that prescriptions of controlled substances for any quantity will be covered by a patient’s prescription drug benefit. III. Can a prescription for a substance in Schedule II be dispensed upon the oral prescription of a practitioner? A. A substance included in Schedule II may be dispensed upon the oral prescription of a prescriber in an emergency (RCW 69.50.308(c)). Further guidance can be found in WAC 246-945-010(6). IV. Can a pharmacy use transportation network companies (TNCs) such as Uber, Lyft, or Postmates to deliver a patient’s prescription medication? A. Possibly --Under Washington law, a TNC could transport a patient’s prescription medication if they are a “common carrier” or “contract carrier” (see RCW 69.41.030(1) and RCW 60.50.302(c)(2)). If a TNC is a “common carrier” or “contract carrier” the TNC would have to obtain a permit from the Washington State Utilities and Transportation Commission (UTC) unless they are exempt . Pharmacies should contact the UTC to verify the status of a “common carrier” or “contract carrier.” Pharmacies should consider other applicable laws and other regulators (e.g., United States Drug Enforcement Administration) before using TNCs to deliver a patient’s prescription medications. For example, the DEA has stated registrants are responsible for selecting common or contract carriers that will provide adequate security against in- transit losses or thefts.

V. Is a pharmacist working under a collaborative drug therapy agreement (CDTA) allowed to prescribe controlled substances? A. A pharmacist working under a collaborative drug therapy agreement (CDTA) may prescribe controlled substance (CS) prescriptions under the following conditions: 1. The scope of the CDTA must permit this activity; and 2. The pharmacist must have a Drug Enforcement Administration (DEA) registration (unless exempted from obtaining a DEA registration, for example see the FAQ on use of the hospital DEA with a suffix). B. Pharmacists acting with prescriptive authority to prescribe CS must have their own unique DEA registration issued by DEA. (From PQAC Newsletter No. 1283 Practitioner DEA Registrations, April 2018 (PDF) Note: DEA regulations are within the authority of the DEA, so final determination on the need for DEA registration lies with the DEA and not the Pharmacy Commission. VI. Is a hospital pharmacist with prescriptive authority under a collaborative drug therapy agreement (CDTA) or other licensed prescribers (such as medical residents) allowed to use their hospital’s DEA number on a controlled substance prescription? A. Yes , if in compliance with applicable DEA regulations. B. The DEA allows any prescriber (as determined by state law) to use the hospital's DEA registration as long as two conditions are met: 1. The prescription or order is entered for drugs to be dispensed and/or administered within the hospital, and 2. The hospital assigns a specific suffix to the end of the hospital's DEA registration that is unique to the prescriber. The specific suffix will be maintained internally by the hospital. C. This might be done with medical residents or other licensed prescribers working within an institutional setting. VII. May a pharmacist dispense a 12-month supply of a contraceptive drug? A. Yes , a pharmacist may dispense a 12-month supply of a contraceptive drug if the prescription is written for an initial supply of 12 months , e.g. 364 tablets of a contraceptive pill. (RCW 48.43.195) B. A pharmacist may not dispense a 12-month supply of a contraceptive drug if the prescription is written for a limited initial supply with refills , e.g. an initial 30-day supply with 11 refills. In this situation, a pharmacist is limited to dispensing a 90-day supply of that prescription. (RCW 18.64.520) VIII. Does the commission need to approve a system used to electronically transmit prescription information to the pharmacy? A. No , this requirement was removed by the passage of SSB 5380 (chapter 314, Laws of 2019). Licensees are responsible for confirming the e-prescribing vendor's software meets the federal e-prescribing requirements. These requirements are outlined in federal regulations, 21 CFR 1311 subpart C. Additionally, WAC 246-945-010 provides the requirements of a prescription in Washington state. IX. May a pharmacist engage in sterile/nonsterile compounding outside a licensed pharmacy? A. Yes , a pharmacist may engage in compounding outside of a licensed pharmacy. B. If yes, is USP still applicable to the pharmacist? 1. RCW 18.64.270(2) require pharmacists, and pharmacy personnel the commission credentials to meet USP standards no matter the facility where compounding is taking place . X. May a pharmacist administer flu vaccinations when operating under a CDTA at a patient’s home? A. A pharmacist would be able to administer vaccines at a patient's home . The pharmacist would still be responsible for the proper packaging and storage of the vaccines while in transit .

XVIII. Do I need to include a separate AUP with my pharmacy technician training program application? A. Yes . Both the technician training program's AUP and the general AUP mentioned above require two separate approvals by the commission. These are two independent processes with the department. These AUPs may be identical or different depending on the duties/responsibilities specified in the technician training program. XIX. Does an individual’s (or business’) acquisition of more than 50 percent of the shares in a pharmacy corporation trigger the commission’s “change of ownership” process? A. Yes , according to statute and rule, pharmacies should immediately notify the commission and comply with the commission's “change of ownership” process if an individual or business acquires more than 50% of the shares in a pharmacy corporation (such as through a stock sale [see RCW 18.64.043(3), WAC 246-945-230(3)(c) and WAC 246-945-992(2)]). XX. Will the commission take enforcement action against licensees or find licensees deficient if they transfer electronic prescriptions for a controlled substance in schedule II through V in compliance with 21 21 CFR §§ 1306.25? A. No . The commission will not take enforcement action against licensees or find licensees deficient if they transfer electronic prescriptions for a controlled substance in schedule II through V in compliance with 21 CFR §§ 1306.08 and 1306.25. The commission will maintain this position until its rulemaking to update WAC 246-945-345 – Prescription transfers is complete, or the commission withdraws this position as part of an open public meeting, whichever occurs first. XXI. Under the legislature’s new compounding law (SHB 1445), should I continue to follow USP requirements when diluting a reconstituted sterile medication, such as Remicade, according to federal food and drug administration-approved labeling? A. Yes , the new compounding law exempts non-sterile and sterile products that only require reconstitution and mixing according to FDA-approved labeling. Further manipulation of a reconstituted product, such as dilution, should be an indicator that compounding is occurring and USP should be followed, per RCW 18.64.270(2). Additionally, under the new pharmacy standard of care rules, the commission expects pharmacists to utilize their professional judgment in the best interest of the patient. XXII. Can a pharmacy supply naloxone to an entity that is not licensed y DOH or to an individual not credentialed by the DOH? A. Yes , under the “Standing Order to Dispense Naloxone” pharmacists are authorized to dispense naloxone to any “eligible person or entity.” The commission will not take enforcement action against a pharmacist or pharmacy for supplying naloxone in good faith and with reasonable care to a non-credentialed entity or non-credentialed provider in accordance with RCW 69.41.095 and the statewide naloxone standing order. B. An example may include a pharmacy providing naloxone to a behavioral health clinic or provider not credentialed by DOH for the purpose of treating substance use disorder in accordance with RCW 70.41.480 and RCW 71.24.594. C. Note: An eligible person or entity is any person at risk of experiencing an opioid-related overdose or any person or entity in a position to assist a person at risk of experiencing an opioid-related overdose. These could include a natural person, such as an individual at risk of an opioid-related overdose or a family member, friend or acquaintance of that individual; or a legal person, such as an ambulance service, police department, or school or other educational institution that could be in a position to assist a person at risk of experiencing an opioid-related overdose.

XXIII. Should a label be affixed to a pre-drawn COVID-19 vaccine syringe? If so, what information should the label include? A. It is important to appropriately label any pre-drawn syringe to minimize the risk of administration errors and vaccine mix-ups. This includes pre-drawn syringes of the COVID-19 vaccine. A label should be affixed to a syringe so that the markings on the barrel of the syringe are not obscured and pertinent label information is easily visible and legible. In keeping with WAC 246-945-018 and per guidance from the Centers for Disease Control and Prevention (CDC) and the United States Pharmacopeia (USP), best practices for pertinent label information include : 1. The vaccine name and amount 2. The expiration date and exact beyond-use date and time 3. Lot number 4. Initials of preparer(s) B. At a minimum, the label should include the information specified in WAC 246-945-018. Other rules may be applicable under certain conditions. C. While the CDC notes that the safest practice is to draw up a dose of COVID-19 vaccine immediately before administration, the Washington State Department of Health recognizes that there are circumstances in which the use of a pre-drawn syringe is necessary. Please consult the CDC website for current beyond-use dating for COVID-19 vaccines, and for further guidance related to storing and handling pre-drawn COVID-19 vaccine syringes.